The FDA is really shaking things up in the sunscreen world and have proposed a Monograph that would list all chemical sunscreens as NOT GRASE (Generally Recognized as Safe and Effective).

FDA Posting On FEBRUARY 26, 2019.

On February 26, 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to establish final monograph regulations for over-the-counter (OTC) sunscreen drug products. If finalized, the rule will update conditions under which OTC sunscreen products may be marketed in the United States.

Since issuing an indefinite stay on a 1999 final monograph, FDA has mostly regulated Sunscreen products under enforcement discretion. In 2011, FDA clarified its enforcement approach to OTC sunscreen products through a draft guidance that was later finalized in 2018. At that point in time, FDA also issued a final rule for the labeling of OTC sunscreen drug products and established mandatory parameters for broad spectrum, sun protection factor (SPF) and water resistance testing.

GRASE Status of Sunscreen Active Ingredients

The rule proposes that zinc oxide and titanium dioxide remain classified as generally recognized as safe and effective (GRASE) for use in sunscreens at concentrations of up to 25 percent.

Aminobenzoic acid and trolamine salicylate would be classified as not GRASE for use in sunscreen as FDA has determined the risks posed by these ingredients outweigh their benefits.

Drug products containing non-GRASE ingredients are considered misbranded and prohibited from being marketed in the U.S.  Additionally, the rule proposes that the following twelve ingredients would be excluded from the final monograph because there is insufficient data to determine whether they are GRASE:

  • Cinoxate
  • Dioxybenzone
  • Ensulizole
  • Homosalate
  • Meradimate
  • Octinoxate
  • Octisalate
  • Octocrylene
  • Padimate O
  • Sulisobenzone
  • Oxybenzone
  • Avobenzone

Many of these ingredients are considered GRASE under the 1999 monograph, meaning sunscreen products with these ingredients can currently be marketed without a new drug application (NDA). If FDA’s new proposed rule becomes final, sunscreen products with these ingredients may not be introduced into interstate commerce one year after the final rule becomes effective. FDA has proposed an effective date for the final rule of November 26, 2019.

I am proud that Absolutely Natural recognized the potential harm in chemical sunscreens almost 30 years ago and were among the first to market 100% mineral sunscreens.   And, as we enter our 28th year, we will always be on the cutting edge of the industry.

Best Regards,